Rabies Vaccine
» Rabies Vaccine conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a sterile preparation, in dried or liquid form, of inactivated rabies virus harvested from inoculated diploid cell cultures. The cell cultures are shown to consist of diploid cells by tests of karyology, to be non-tumorigenic by tests in hamsters treated with anti-lymphocytic serum (ALS) and to be free from extraneous agents by tests in animals or cell-culture systems. The harvested virus meets the requirements for identity by serological tests, for absence of infectivity by tests in mice or cell-culture systems, and for absence of extraneous agents by tests in animals or cell-culture systems. The Vaccine meets the requirements for absence of live virus by tests using a suitable virus amplification system involving inoculation and incubation of sensitive cell cultures for not less than 14 days followed by inoculation of the cell-culture fluid thereafter into not less than 20 adult mice. It has a potency of rabies antigen equivalent to not less than 2.5 International Units for Rabies Vaccine, per dose, determined with the specific mouse protection test using the U.S. Standard Rabies Vaccine. It meets the requirements for general safety (see Safety Tests—Biologicals under Biological Reactivity Tests, in Vivo 88).
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date is not later than 2 years after date of issue from manufacturer's cold storage (5, 1 year).
Labeling— Label it to state that it contains rabies antigen equivalent to not less than 2.5 IU per dose and that it is intended for intramuscular injection only.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Tina S. Morris, Ph.D.
Director,Biologics and Biotechnology
(BBVV05) Biologics and Biotechnology - Vaccines and Virology
USP32–NF27 Page 3469